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Audit Management Checklists

For Life Science and Manufacturing Companies, Initiating an Audit Program that Provides Effective Audit Management Checklists is Crucial.

Pharmaceutical, biotechnology, medical device, laboratories, and blood / tissue companies can all benefit from an audit management checklist that is useful, reliable, and helpful in achieving regulatory compliance. To be effective, the checklist for performing a system audit need not be elaborate. However, it is necessary for the audit management checklist to include all the essential items that must be addressed during an audit. MasterControl Audit's comprehensive audit management checklists feature highlights the most important areas of an audit program.

Preparing Audit Management Checklists

Whether your company is preparing for an internal audit or an audit subject to external regulatory guidelines (such as FDA, ISO, CLIA, etc.), many of the same basic principles apply when it comes to making an audit management checklist. For instance, the audit checklists should ask:

What is it that the quality auditor will be inspecting? (clinical trials, CAPA processes, training procedures, etc.)

Was the system audit provoked or is it a routine procedure?

Will the auditor need access to specific documentation to prepare the audit report? (If so, this should be noted on the audit management checklist.)

Is there a planned methodology for the quick retrieval of documentation and proof of all essential audit trails?

Will the auditor need to talk with specific personnel as they follow the audit procedures?

MasterControl Offers Software that Facilitates the Development of Effective Audit Management Checklists

MasterControl is a leading provider of document, quality, and audit management software solutions that enable life science and other companies to streamline quality by facilitating the creation of efficient and effective audit management checklists. These audit management checklists allow organizations to complete required processes in a fraction of the time otherwise required for manual or hybrid processes. In addition, MasterControl Audit is specifically designed to cater to any type of audit including internal, external, or customer. In order to accommodate the audit needs of companies belonging to a wide range of industries, the software provides a highly customizable audit management checklist. With MasterControl Audit, companies are provided a unique yet compliant approach to developing audit management checklists.

The first stage for any company establishing an audit program is planning. This phase is crucial as it helps in drawing out a road map that defines the purpose, focus, and approach of the audit. Management can then determine the goals, objectives, and scope of the audit.

The next crucial phase is the development of a functional, free-flowing dialogue between personnel and teams involved in audit processes. MasterControl Audit is web-based, which establishes an online dialogue directly through the portal. This allows auditors, vendors, employees, and other stakeholders of the company to be on same page regarding the requirements of the audit management checklist. The active involvement of all users serves as a common ground for establishing direct communication in sketching out the audit requirements. With MasterControl Audit, users can assess risks involved in an audit and prepare a foolproof system that is prepared for mitigating, monitoring and managing any type of potential risk. Furthermore, MasterControl's Audit solution guides companies through the process of tracking and reporting on audit findings.

Once an audit management checklist is prepared, the next step is to execute the audit program. Management must communicate with the auditors and confirm audit results in order to verify the audit findings. For larger companies, this process can be an overwhelming task for evaluating people and procedures in the system. MasterControl Audit helps define "finding categories" that are often linked to specific regulatory requirements (rather than, strictly speaking, to an audit management checklist). This functionality facilitates the investigation of potential problems that may have been unforeseen. For an audit to be effective, the audit program must be transparent. MasterControl Audit facilitates transparency by providing supervisors and executives with audit management checklists that allow them to examine each stage of the audit. In addition, users are able to collaborate to achieve an optimum audit. It also allows companies to report / trend in a manner compliant with FDA guidelines.

MasterControl Audit presents comprehensive audit reporting functionality that elaborates upon the audit findings for management. These findings serve as a foundation for planning and developing corrective actions in the system. A thorough audit management checklist helps management draw accurate findings that are then used for executing effective CAPAs. In summary, a sound audit management checklist helps define the direction management should take when implementing business changes. MasterControl Audit provides management with the essential tools for executing an efficient audit program that helps customers conduct business profitably and stay competitive in the market.

For More Information on Audit Management Checklists

For more information about conducting audits and the most beneficial approaches for developing audit management checklists, please feel free to contact a MasterControl representative

The QMS Provider for the FDA

MasterControl Inc. and its partner, i4DM, are expanding their FDA project, serving as the QMS providers for a second FDA division. The two companies have been the QMS providers for the FDA's Office of Regulatory Affairs since 2009. Now they will also serve as quality providers for the Division of Pharmaceutical Analysis, which is part of the FDA's Center for Drug Evaluation and Research.